Hepatic safety of tipranavir plus ritonavir (TPV/r)-based antiretroviral combinations: effect of hepatitis virus co-infection and pre-existing fibrosis.
OBJECTIVE
The aim of this study was to evaluate the incidence and risk factors of severe liver events among HIV-infected patients treated with drug combinations including tipranavir boosted with ritonavir (TPV/r).


METHODS
One hundred and fifty patients were selected because they started a regimen that included TPV/r (500/200 mg twice a day) and had clinical visits at least every 3 months. Patients who discontinued TPV/r before their first visit were included.


RESULTS
Twelve (8%) individuals developed grade>or=3 transaminase elevation (G>or=3TE). Nine (6%) patients discontinued TPV/r due to liver events. Six (8.6%) of 70 hepatitis C virus (HCV) co-infected patients and 6 (7.5%) of 80 subjects without HCV co-infection developed G>or=3TE (P=1). Liver fibrosis was evaluable in 48 (63%) of 76 individuals with hepatitis B virus and/or HCV infection. Four (13%) of 30 subjects with moderate-to-severe fibrosis and none of 18 with mild fibrosis showed G>or=3TE (P=0.3). None of nine patients with cirrhosis showed G>or=3TE.


CONCLUSIONS
Liver tolerability of TPV/r was generally good in a cohort of patients with a high proportion of HCV co-infection, including subjects with advanced fibrosis. The presence of HCV co-infection was not associated with an increased risk of severe transaminase elevations.
Macías
Juan
J
Unidad de Enfermedades Infecciosas, Hospital Universitario de Valme, Seville, Spain.
Orihuela
Francisco
F
Rivero
Antonio
A
Viciana
Pompeyo
P
Márquez
Manuel
M
Portilla
Joaquín
J
Ríos
María J
MJ
Muñoz
Leopoldo
L
Pasquau
Juan
J
Castaño
Manuel A
MA
Abdel-Kader
Laila
L
Pineda
Juan A
JA
D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D019698:Hepatitis C, Chronic; D006801:Humans; D008103:Liver Cirrhosis; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use*; D011753:Pyrones / Q000009:adverse effects* / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects* / Q000627:therapeutic use*; D013449:Sulfonamides; D000637:Transaminases / Q000097:blood
D044966:Anti-Retroviral Agents; D011725:Pyridines; D011753:Pyrones; D013449:Sulfonamides; D000637:Transaminases; D019438:Ritonavir; C107201:tipranavir